
Global Regulatory Affairs Professional
2 days ago
We are seeking a highly skilled Regulatory Affairs professional to support global submissions.
- Key Responsibilities:
- Prepare variation documents and evaluate post-approval changes in compliance with regulatory requirements.
- Contribute to Lifecycle Management activities by compiling and reviewing CTD dossier modules.
- Compile initial dossiers for global markets, ensuring compliance with international regulations.
- Provide regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage the compilation and submission of variations and supplements for global markets.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Review technical documents from manufacturing sites, including specifications, batch records, process validations, analytical data, and stability information.
Requirements:
- 3+ years of experience in managing global submissions, variations, and full lifecycle deliverables.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory requirements for global markets.
- Hands-on experience in initial dossier compilation for global markets.
- Experience in providing regulatory strategies and evaluation by performing assessments of post-approval changes.
-
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